Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

Inclusion Criteria

• •1. HIV-1 infection
• •2. Effective antiviral therapy for HIV (ART) and HBV that includes TDF, TAF, TDF/FTC, TDF/3TC (tenofovir disoproxil fumarate plus lamivudine), TAF/FTC, or entecavir (ETV), for ≥5 years immediately prior to study entry. ART is defined as including a minimum of two anti-HIV antivirals.
• •3. CD4+ cell count ≥350 cells/mm3
• •4. HIV-1 RNA \<50 copies/mL measured on at least two occasions at least 12 weeks apart, with no documented value \>200 copies/mL, over the 12 months prior to study entry.
• •5. Positive or negative HBeAg
• •6. Negative anti-HDV
• •7. Current CHB infection
• •8. HBV DNA level \<50 IU/mL measured on at least two occasions at least 12 weeks apart, with no documented value ≥50 IU/mL, over the 12 months prior to study entry.
• •9. Quantitative HBsAg \>1000 IU/mL
• •10. Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
• •11. Participants age ≥18 years and ≤70 years at study entry
• •12. Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.